Avail

K172079 · Omron Healthcare, Inc. · NUH · Oct 19, 2017 · Neurology

Device Facts

• Record ID: K172079
• Device Name: Avail
• Applicant: Omron Healthcare, Inc.
• Product Code: NUH · Neurology
• Decision Date: Oct 19, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Software as a Medical Device, Therapeutic

Intended Use

The Avail is intended for the relief of pain associated with sore or aching muscles of the lower back, arms, legs, shoulders or feet due to strain from exercise or normal household work activities. When used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis, use the Tap, Shoulder, Arm or Leg mode of stimulation.

Device Story

Avail (Model PM601) is a wireless, dual-channel wearable electrotherapy device for chronic muscle/joint pain. System includes two rechargeable TENS units, medium/large gel pads, and AC charger. Operated via dedicated iOS/Android app; user selects from nine TENS modes or one microcurrent therapy mode. Pads applied to intact skin; app controls treatment duration, intensity, and mode. Used in clinics, hospitals, or home environments by adult patients. Provides symptomatic pain relief through TENS and microcurrent stimulation; helps manage chronic/arthritis pain. Healthcare providers/patients use app interface to monitor therapy status, battery, and settings.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including performance verification, usability testing in simulated home environments, biocompatibility (ISO 10993-1), electrical safety, and electromagnetic compatibility (EMC) testing.

Technological Characteristics

Wireless dual-channel TENS/microcurrent stimulator. Rechargeable Li-ion battery. Biphasic rectangular waveforms. Connectivity via Bluetooth to smartphone app. Biocompatible patient-contacting pads. Complies with ES 60601-1, IEC 60601-1-2, IEC 60601-2-10, and IEC 60601-1-11. Microprocessor-controlled. Non-sterile.

Indications for Use

Indicated for adult patients for relief of pain associated with sore/aching muscles of lower back, arms, legs, shoulders, or feet due to exercise or household strain. Also indicated for symptomatic relief/management of chronic, intractable pain and arthritis pain using specific stimulation modes. Contraindicated for patients with cardiac pacemakers, implanted defibrillators, or other implanted metallic/electronic devices.

Regulatory Classification

Identification

A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.

Predicate Devices

• Philips Consumer Lifestyle PulseRelief (K151035)

Reference Devices

• Chattem, Inc. SmartRelief (K131159)
• Omron Heat Pain Pro (K160115)
• Painmaster MCT Patch (K130114)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration."

October 19, 2017

Omron Healthcare, Inc. % Ronald Warren Senior Director, Regulatory Affairs Experien Group 224 Airport Parkway, Suite 250 San Jose, California 95110

Re: K172079

Trade/Device Name: Avail. Model PM601 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH Dated: July 7, 2017 Received: July 10, 2017

Dear Ronald Warren:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

William J. Heetderks -S 2017.10.19 18:10:10 -04'00'

- for Carlos L. Peña. PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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## Indications for Use

510(k) Number (if known) K172079

Device Name Avail Model PM601

Indications for Use (Describe)

The Avail is intended for the relief of pain associated with sore or aching muscles of the lower back, arms, legs, shoulders or feet due to strain from exercise or normal household work activities.

When used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis, use the Tap, Shoulder, Arm or Leg mode of stimulation.

Environments of Use: Clinics, hospital and home environments Patient Population: Adult

Type of Use (Select one or both, as applicable)

- Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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### 510(k) Notification K172079

#### GENERAL INFORMATION [807.92(a)(1)]

### Applicant:

Omron Healthcare, Inc. 1925 West Field Court Lake Forest, IL 60045 USA Phone: [phone] FAX: [phone]

## Contact Person:

Ronald S. Warren Senior Director, Regulatory Affairs Experien Group, LLC 224 Airport Parkway, Suite 250 San Jose, CA 95110 USA Phone: [phone] FAX: [phone]

Date Prepared: October 19, 2017

### DEVICE INFORMATION [807.92(a)(2)]

### Trade Name:

Avail™ (Model PM601)

### Generic/Common Name:

Transcutaneous Electrical Nerve Stimulator for Pain Relief

#### Classification:

Class II per 21CFR882.5890

## Product Code:

NUH and NYN

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## PREDICATE DEVICE(S) [807.92(a)(3)]

The Omron Avail™ (Model PM601) TENS device ("Avail") is substantially equivalent to the primary predicate device, the Philips Consumer Lifestyle PulseRelief (K151035) TENS, with regard to product labeling, intended use, anatomical sites, patient population. performance testing, technological characteristics and safety characteristics. In addition, the Avail device is similar to two other devices (i.e. reference devices), the Chattem, Inc. SmartRelief (K131159) TENS and the Omron Heat Pain Pro (K160115) with regard to indications for use and TENS function. The Avail is also similar to the Painmaster MCT Patch (K130114) with respect to delivery of microcurrent (low-level electrical stimulation).

## DEVICE DESCRIPTION [807.92(a)(4)]

The Avail device is a wireless, independent dual channel wearable electrotherapy device that is designed to alleviate chronic muscle and joint pain on multiple body locations. It delivers TENS (Transcutaneous Electrical Nerve Stimulation) technology and microcurrent therapy through the simple, convenient use of the dedicated Omron TENS iOS or Android App. Reusable, self-adhesive, contouring pads allow for discreet and convenient placement on multiple pain locations on the body. The Avail system can be programmed to deliver nine different TENS modes and a microcurrent therapy mode.

The system contains two main TENS units which are rechargeable and each can be attached to either a medium or large size gel pad. The pad with attached TENS unit can then be applied to intact skin at the desired location for therapy and pain relief. Control of the Avail TENS system is completed through the available Omron TENS App. The Avail will be packaged with an Instruction Manual which provides details on setting up the device for use, installing of the Omron TENS App, setting and controlling therapy modes, and troubleshooting. The system includes two main TENS units, medium and large pads, an AC-powered charger, AC adapter, a pad holder and storage case.

## INDICATIONS FOR USE [807.92(a)(5)]

The Avail is intended for the relief of pain associated with sore or aching muscles of the lower back, arms, legs, shoulders or feet due to strain from exercise or normal household work activities.

When used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis, use the Tap, Shoulder, Arm or Leg mode of stimulation.

Environments of Use: Clinics, hospital and home environments Patient Population: Adult

## COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES [807.92(a)(6)]

In regard to technological characteristics, the Avail device is similar to the predicate and reference TENS devices. Like the predicate PulseRelief device is paired

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and controlled by a dedicated smartphone App. The mode, treatment duration and intensity can only be controlled by the App. However, both proposed and predicate devices can be turned off by pressing the on/off button on the main unit or button on App.

The Avail device offers nine different TENS treatment modes and a microcurrent mode, whereas the PulseRelief offers fifteen TENS treatment modes and five EMS (electrical muscle stimulation modes. Seven of the nine Avail waveforms are the same as the modes for the Heat Pain Pro reference device. The Avail device also offers a microcurrent mode, which is a minor technological difference as compared to the primary predicate device. The Avail device also offers a microcurrent mode, which is a minor technological difference as compared to the primary predicate device. To address this difference, reference is made to the Painmaster MCT Patch (K130114) which uses a microcurrent low-level electrical stimulation and shares the same regulation number (21 CFR 882.5890) and product code (NUH) as the proposed Avail device. The microcurrent mode is considered a very low current TENS (rectangular biphasic waveform) delivered at a very low frequency. A comparison of the Avail waveforms to the primary predicate and reference devices was included in this 510(k) submission.

In addition, the Avail offers certain TENS modes for treatment of arthritis pain. As specified in the proposed indications for use statement, Chronic intractable pain and arthritis pain can be treated with Avail using the Tap, Shoulder, Arm or Leg Mode. This intended use is the same as the SmartRelief reference device. Although the Avail waveforms are different from the single waveform of the SmartRelief device, the electrical parameters of both are quite similar. This is due to the presence of:

- High frequency (50+) Hz for chronic pain that requires non-contracting ● stimulation modes for a comfortable smoother therapy for chronic pain therapy
- Modulation via different pulse trains to prevent muscle accommodation for both chronic pain and arthritis
- . Variation of both high and low rate pulses within the mode to address both muscle and joint pain from arthritis and various chronic pain

A detailed comparison of the Avail waveforms to the SmartRelief waveform in the context of treatment of arthritis pain was provided in this submission.

In regard to other technological characteristics, summary tables of output parameters for the Avail, predicate and reference devices were also provided in this submission. In general, the Avail output parameters fall within the range of output parameters for PulseRelief. For example, the maximum current density (mA/cm2) range for Avail is 0.0008 ~ 0.17, while the PulseRelief range is 0.12 ~ 0.44. This range is also well below the IEC60601-2-10:2012 (Clause 201.4.2) limit of less than 2mA/cm². The maximum average power density (W/cm2) range is 1.4x10 ~ 6.8x10 * for Avail, whereas the PulseRelief maximum average power density range is 1.9x10- ~ 2.36x103 .

In regard to treatment duration, the instructions for use of the PulseRelief provide no specified time duration for six treatment modes (Conventional, Thorough stimulus, Preactivity. Soft stimulus, Deep stimulus, Radiating pulse). For Avail, the selectable time duration for TENS therapy is 5 to 60 minutes (in 5 minute increments). The selectable time duration for Microcurrent therapy is 30 to 180 minutes (in 30 minute increments).

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The labeling of the Painmaster MCT Patch for microcurrent therapy indicates the device can be used continuously for up to 300 hours. Thus, the PulseRelief has higher current density, power density and longer recommended treatment time ranges compared to Avail. In this regard. Avail should be considered at least as the PulseRelief, while offering similar TENS modes for pain therapy. Further, the Avail microcurrent recommended therapy durations falls within the range recommended for the Painmaster MCT Patch.

### SUBSTANTIAL EQUIVALENCE

The proposed device, predicate device and reference devices are all intended for use as transcutaneous electrical nerve stimulation in adult populations for use in clinic. hospital or home settings. Omron has completed comprehensive design verification testing. electrical safety and electromagnetic compatibility testing, software verification and validation, and usability testing to ensure that the Avail device performs as intended. The Avail also passed testing requirements for electrical safety and EMC, and the device patient-contacting were tested to demonstrate biocompatibility. The minor differences in labeling and technological characteristics between the proposed device and the predicate device have been evaluated and determined to not raise different questions of safety or effectiveness. As such, the proposed Avail is substantially equivalent to the predicate device. A comparison table summarizing the specifications and features of the proposed Avail device, the predicate and reference devices is included in the Substantial Equivalence Table (Table 1) below.

In regard to other technological characteristics, summary tables (Tables 2. 3. 4 and 5) of output parameters for the Avail, predicate and reference devices are provided below.

#### PERFORMANCE DATA [807.92(b)]

All necessary non-clinical and usability testing was conducted on the Avail to confirm that the device performs as intended.

#### Nonclinical Testing Summary:

The nonclinical, bench testing included:

- Performance verification to confirm acceptable performance of device features and functions
- . Usability testing with a representative population of study participants in a simulated home use environment

Other nonclinical safety testing included:

- . Biocompatibility of patient-contacting materials per ISO 10993-1 requirements
- . Electrical safety and electromagnetic compatibility testing
- Software verification and validation ●

The collective results of the nonclinical testing demonstrate that the materials chosen, the manufacturing processes, and design of the Avail meet the established specifications

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necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that the Avail does not raise different questions of safety or effectiveness for TENS therapy when compared to the predicate devices.

### Clinical Testing Summary:

Not applicable. Clinical testing was not performed to support this 510(k) submission.

### CONCLUSIONS [807.92(b)(3)]

Based on the results from the nonclinical and usability tests performed in support of Avail, it is concluded that the proposed device is safe, is effective, and performs at least as safely and effectively as the legally marketed predicate device.

#### SUMMARY

The proposed device, predicate device and reference devices are all intended for use as transcutaneous electrical nerve stimulation in adult populations for use in clinic. hospital or home settings. Omron has completed comprehensive design verification testing, electrical safety and electromagnetic compatibility testing, software verification and validation, and usability testing to ensure that the Avail device performs as intended. The A vail also passed testing requirements for electrical safety and EMC, and the device patient-contacting components were tested to demonstrate biocompatibility. The minor differences in labeling and technological characteristics between the proposed device and the predicate device have been evaluated and determined to not raise different questions of safety or effectiveness. As such, the proposed Avail is substantially equivalent to the predicate device.

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Table 1. Substantial Equivalence Summary

| Feature | Proposed Device<br>Omron Avail<br>Wireless Dual<br>Channel TENS<br>PM601 | Primary Predicate<br>Device<br>Philips PulseRelief<br>(K151035) | For TENS Function | | For Microcurrent | Analysis of Technological<br>Differences | |
|---------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| Classification-<br>Regulation | 21 CFR§882.5890,<br>Transcutaneous<br>electrical nerve<br>stimulator for pain<br>relief | 21 CFR§882.5890,<br>Transcutaneous<br>electrical nerve<br>stimulator for pain<br>relief | 21 CFR§882.5890,<br>Transcutaneous<br>electrical nerve<br>stimulator for pain<br>relief | 21 CFR§882.5890,<br>Transcutaneous<br>electrical nerve<br>stimulator for pain<br>relief | 21 CFR§882.5890,<br>Transcutaneous<br>electrical nerve<br>stimulator for pain<br>relief | No difference. Proposed<br>device and predicate<br>devices have the<br>same medical device<br>classification number. | |
| Classification-<br>Product Code | Primary: NUH -<br>Transcutaneous<br>electrical nerve<br>stimulator for pain<br>relief<br>Secondary: NYN-<br>Transcutaneous<br>electrical nerve<br>stimulator for pain<br>relief. | Primary: NUH -<br>Transcutaneous<br>electrical nerve<br>stimulator for pain<br>relief<br>Secondary: NGX -<br>Stimulator, Muscle,<br>Powered, For Muscle<br>Conditioning | Primary: NUH -<br>Transcutaneous<br>electrical nerve<br>stimulator for pain<br>relief<br>Secondary: NYN-<br>Transcutaneous<br>electrical nerve<br>stimulator for pain<br>relief. | NUH -<br>Transcutaneous<br>electrical nerve<br>stimulator for pain<br>relief | NUH -<br>Transcutaneous<br>electrical nerve<br>stimulator for pain<br>relief | No difference. Proposed<br>device and predicate<br>devices have the<br>same medical device<br>product code. | |
| Indications for Use | The Avail is intended<br>for the relief of pain<br>associated with sore or<br>aching muscles of the<br>lower back, arms, legs,<br>shoulders or feet due<br>to strain from exercise<br>or normal household<br>work activities.<br>When used for the<br>symptomatic relief and<br>management of<br>chronic, intractable<br>pain and relief of pain<br>associated with | The OTC<br>TENS/EMS<br>stimulator<br>PulseRelief is<br>designed to be used<br>for temporary relief<br>of pain associated<br>with sore and<br>aching muscles in the<br>shoulder, waist, back,<br>neck, upper<br>extremities (arm) and<br>lower extremities<br>(leg) due to strain<br>from exercise or | To be used for<br>temporary relief of<br>pain associated<br>with sore and<br>aching muscles due<br>to strain from<br>exercise or normal<br>household and<br>work activities.<br>To be used for<br>symptomatic relief<br>and management of<br>chronic, intractable<br>pain and relief of<br>pain associated | The Omron Heat Pain<br>Pro is intended for:<br>The relief of pain<br>associated with sore<br>or aching, muscles of<br>the lower back, arms,<br>legs, shoulder, or foot<br>due to strain from<br>exercise or normal<br>household work<br>activities.<br>Environments of Use:<br>Clinics, hospital and<br>home environments<br>Patient Population: | The Painmaster<br>MCT Patch is<br>indicated for<br>temporary relief of<br>pain associated<br>with sore and<br>aching muscles in<br>upper and lower<br>extremities (arm<br>and/or leg) due to<br>strain from exercise<br>or normal<br>household and<br>work activities. | Similar to PulseRelief and<br>Heat Pain Pro for<br>temporary relief of pain<br>with sore and aching<br>muscles. Similar to<br>SmartRelief with respect to<br>symptomatic relief and<br>management of chronic,<br>intractable pain, and relief<br>of pain associated with<br>arthritis. | |
| Feature | Proposed Device<br>Omron Avail<br>Wireless Dual<br>Channel TENS<br>PM601 | For TENS Function | | For Microcurrent | Analysis of Technological<br>Differences | | |
| | | Primary Predicate<br>Device<br>Philips PulseRelief<br>(K151035) | Reference Device<br>SmartRelief<br>(K131159) | Reference Device<br>Omron Heat Pain<br>Pro (K160115) | Reference Device<br>Painmaster MCT<br>Patch (K130114) | | |
| | arthritis, choose Tap,<br>Shoulder, Arm or Leg<br>mode.<br>Environments of Use:<br>Clinics, hospital and<br>home environments<br>Patient Population:<br>Adult | normal household<br>work activities.<br>It should be applied<br>to normal, healthy,<br>dry and clean skin of<br>adult patients, and is<br>to be used to<br>stimulate healthy<br>muscles in order to<br>improve and facilitate<br>muscle performance. | with arthritis. | Adult | | | |
| Environment of Use | Clinics, hospitals and<br>home environments | Home | Unknown | Clinics, hospital and<br>home environments | Home | Same as Heat Pain Pro,<br>SmartRelief and<br>Painmaster | |
| Patient Population | Adults | Adults | Adults | Adults | Over 12 years of<br>age, unless under<br>physician<br>supervision | Predicate device intended<br>for same population.<br>Painmaster indicated for<br>over 12 years of age, unless<br>physician supervised. | |
| Feature | Proposed Device<br>Omron Avail<br>Wireless Dual<br>Channel TENS<br>PM601 | For TENS Function | | | For Microcurrent | Analysis of Technological<br>Differences | |
| | | Primary Predicate<br>Device<br>Philips PulseRelief<br>(K151035) | Reference Device<br>SmartRelief<br>(K131159) | Reference Device<br>Omron Heat Pain<br>Pro (K160115) | Reference Device<br>Painmaster MCT<br>Patch (K130114) | | |
| Contraindications/<br>Warnings/<br>Precautions | Contraindications<br>Do not use this device<br>if you have a cardiac<br>pacemaker, implanted<br>defibrillator, or other<br>implanted metallic or<br>electronic device.<br>Such use could cause<br>electric shock, burns,<br>electrical interference,<br>or death. | Contraindications<br>Do not use this<br>device with the<br>following medical<br>devices:<br>-- Implanted<br>electronic medical<br>devices, such as<br>pacemakers.<br>This may cause<br>electric shock, burns,<br>or death.<br>-- Electronic life<br>support equipment,<br>such as respirators.<br>-- Electronic medical<br>devices worn on the<br>body, such<br>as<br>electrocardiographs.<br>If you use this device<br>together with other<br>electronic<br>medical devices,<br>these devices may not<br>work correctly. | Contraindications<br>Do not use this<br>device if you have<br>a cardiac<br>pacemaker,<br>implanted<br>defibrillator, or<br>other implanted<br>metallic or<br>electronic device.<br>Such use could<br>cause electric<br>shock, burns,<br>electrical<br>interference, or<br>death. | Contraindications<br>Do not use this<br>device if you have a<br>cardiac pacemaker,<br>implanted<br>defibrillator, or other<br>implanted metallic or<br>electronic device.<br>Such use could cause<br>electric shock, burns,<br>electrical<br>interference, or death. | Contraindications<br>Do not use with<br>pacemakers or<br>anyone using<br>transdermal drug<br>delivery<br>Do not place<br>patches along neck<br>Do not place<br>patches in a way<br>that causes flow of<br>current through<br>head | Contraindications are<br>similar for all devices. | |
| Feature | Proposed Device<br>Omron Avail<br>Wireless Dual<br>Channel TENS<br>PM601 | | For TENS Function | For Microcurrent | Analysis of Technological<br>Differences | | |
| | Primary Predicate<br>Device<br>Philips PulseRelief<br>(K151035) | Reference Device<br>SmartRelief<br>(K131159) | Reference Device<br>Omron Heat Pain<br>Pro (K160115) | Reference Device<br>Painmaster MCT<br>Patch (K130114) | | | |
| Single Use | Patient-contacting<br>Pads are for single<br>patient use | Patient-contacting<br>electrodes are for<br>single patient use | Unknown | Pads are for single<br>patient use | Pads should only<br>be used by one<br>person | No difference. Proposed<br>and predicate TENS<br>devices are durable<br>medical equipment<br>intended for multiple uses.<br>Patient-contacting<br>components are for use by<br>a single adult patient. | |
| Sterility | External contacting<br>device, nonsterile | Unknown | Unknown | External contacting<br>device, nonsterile | Unknown | No difference. Proposed<br>and predicate device are<br>provided<br>nonsterile. | |
| Specification/Features | | | | | | | |
| Over-the-Counter<br>(OTC) | Yes | Yes | Yes | Yes | Yes | No difference | |
| Power Source(s) | Rechargeable Lithium-<br>ion battery | Rechargeable<br>Lithium-ion battery | 3V CR2032<br>lithium battery | Rechargeable<br>Lithium-ion battery | Primary battery<br>only. One-time use. | Same battery type as Heat<br>Pain Pro and PulseRelief | |
| Method of Line<br>Current Isolation | N/A (internal power<br>source) | N/A | N/A | N/A (internal power<br>source) | N/A | No difference | |
| Patient Leakage<br>Current: | --- | --- | --- | --- | --- | --- | |
| -Normal Condition<br>(uA) | $<10$ uA | $<10$ uA | Unknown | 1 | Unspecified | Same as PulseRelief | |
| -Single Fault<br>Condition (uA) | $<50$ uA | $<50$ uA | Unknown | 5.52 max | Unspecified | Same as PulseRelief | |
| Feature | Proposed Device<br>Omron Avail<br>Wireless Dual<br>Channel TENS<br>PM601 | Primary Predicate<br>Device<br>Philips PulseRelief<br>(K151035) | For TENS Function | | | For Microcurrent | Analysis of Technological<br>Differences |
| | | | Reference Device<br>SmartRelief<br>(K131159) | Reference Device<br>Omron Heat Pain<br>Pro (K160115) | | Reference Device<br>Painmaster MCT<br>Patch (K130114) | |
| Average DC current<br>through electrodes<br>when device is on<br>but no pulse are<br>being applied (uA) | 0 | 0 | 0 | 0 | | 0 | No difference |
| Number of output<br>Modes | 9 TENS modes<br>1 Microcurrent mode | 15 TENS<br>5 EMS…